日本药典-孟鲁司特钠-英文.pdf

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1、001-1409-2(仮訳).pdfcomparethespectrumwiththespectrumofMontelukastSo-MontelukastSodiumdiumRS:bothspectraexhibitsimilarintensitiesofabsorp-モンテルカストナトリウムtionatthesamewavenumbers.Purity(1)Heavymetals－Dissolve0.5gofMontelukastSodiumin20mLofamixtureofacetoneandwater(4:1),anduseth

2、issolutionasthesamplesolution.Separately,take0.5mLofStandardLeadSolution,add20mLofthemixtureofacetoneandwater(4:1),andusethissolutionasthestand-ardsolution.Tothesamplesolutionandthestandardsolutionadd2mLofacetatebuffersolution,pH3.5,andshake.Tothesesolutionsadd1.2mLofthio

3、acetamide-alkalineglycerinC35H35ClNNaO3S:608.17TS,shakeimmediately,thenallowtostandfor2minutes,Sodium(1-{[((1R)-1-{3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]andfilterthroughamembranefilterwithporesize0.45µmphenyl}-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl)sulfanyl](about

4、13mmindiameter).Comparethecoloronthemem-methyl}cyclopropyl)acetatebranefiltersthroughwhicheachsolutionisfiltered:thecolor[151767-02-1]obtainedfromthesamplesolutionisnotdarkerthanthatobtainedfromthestandardsolution(notmorethan10ppm).MontelukastSodiumcontainsnotlessthan98.0

5、%(2)Relatedsubstances－Conductthisprocedureusingandnotmorethan102.0%ofC35H35ClNNaO3S,calcu-light-resistantvessels.Dissolve50mgofMontelukastSo-latedontheanhydrousbasisandcorrectedonthediumin50mLofamixtureofmethanolandwater(9:1),amountoftheresidualsolvent.andusethissolutiona

6、sthesamplesolution.PerformthetestDescriptionMontelukastSodiumoccursasawhitetopalewith10µLofthesamplesolutionasdirectedunderLiquidyellowishwhitepowder.Chromatography<2.01>accordingtothefollowingcondi-Itisverysolubleinmethanolandinethanol(99.5),andtions.Determineeachpeakare

7、abytheautomaticintegrationfreelysolubleinwater.method,andcalculatetheamountofthembytheareaper-Itishygroscopic.centagemethod:theamountofthepeakhavingtherelativeItturnsyellowonexposuretolight.retentiontimeofabout1.9tomontelukast(relatedsubstanceF)isnotmorethan0.3%,theamount

8、ofthepeakhavingtheIdentification(1)Place0.1gofMontelukastSodiuminrelativeretentiontimeofabout0.4